FDA 510(k) Application Details - K102860

Device Classification Name Accessories, Soft Lens Products

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510(K) Number K102860
Device Name Accessories, Soft Lens Products
Applicant ALCON RESEARCH, LTD.
6201 SOUTH FREEWAY
FORT WORTH, TX 76134-2099 US
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Contact BETH L SCHULTZ
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Regulation Number 886.5928

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Classification Product Code LPN
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Date Received 09/30/2010
Decision Date 05/10/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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